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FDA 510(k)

ECHOSOFT(TM)

K-Number: K111142 · 2012-09-21

ApplicantEchometrix, LLC
Decision Date2012-09-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHOSOFT(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Echometrix, LLC. It received FDA 510(k) clearance on 2012-09-21 under 510(k) number K111142. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOSOFT(TM)?

ECHOSOFT(TM) is a medical device that received FDA 510(k) clearance on 2012-09-21. The listed applicant is Echometrix, LLC. The 510(k) number is K111142.

When did ECHOSOFT(TM) receive FDA 510(k) clearance?

ECHOSOFT(TM) received FDA 510(k) clearance on 2012-09-21, under 510(k) number K111142.

Who is the listed applicant for ECHOSOFT(TM)?

The FDA 510(k) record lists Echometrix, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHOSOFT(TM)?

The FDA product code for ECHOSOFT(TM) is LLZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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